C49
Conditions
Interventions
Group 1: Single-arm study cohort: Patients with a soft-tissue tumour of indeterminate dignity for whom a core needle biopsy is indicated to establish the diagnosis are included. During the biopsy that
all included participants undergo the same procedure.
Sponsors
Universitätsklinik für Plastische Chirurgie, Handchirurgie und Schwerbrandverletzte, BG Universitätsklinikum Bergmannsheil gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients with a soft-tissue tumour of unclear or indeterminate dignity for whom a core needle biopsy is the diagnostic method of choice and who consent to it. Histological classification (malignant, intermediate or benign) is only established after enrolment; all cases enrolled in this way – including findings that turn out to be histologically benign – generally remain in the study cohort as a comparison group. Age between 18 and 90 years Capacity to consent and written informed consent provided
Exclusion criteria
Exclusion criteria: Age under 18 years Lack of capacity to consent (e.g. psychiatric impairment, mechanical ventilation, persons under legal guardianship) Concomitant conditions with potential confounding influence, in particular autoimmune diseases and concurrent malignancies other than soft-tissue sarcomas Difficult-to-access tumours that must be secured by incisional biopsy as a last resort Retroperitoneal or intrathoracic tumours Vascular malformations Lesions smaller than 1.5 cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the determination and systematic description of the protein and mRNA expression profiles in the study-specific tissue samples obtained from different soft-tissue tumour and soft-tissue sarcoma entities. Determination is performed by immunohistochemistry, Western blot, quantitative PCR (qPCR) and further RNA-based expression analyses on pseudonymised, cryopreserved tissue samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints comprise the comparison of protein expression profiles between different histological soft-tissue tumour entities, the comparison of mRNA expression profiles between these entities, the comparison of malignant and – where present in the cohort – benign soft-tissue tumours, and the correlation of the molecular findings with the available clinical and histopathological parameters (including histological entity and the characteristics recorded in the case report form). In addition, molecular patterns of potential diagnostic or biological relevance are identified in an exploratory manner. Survival, recurrence, metastasis or treatment-effect endpoints, as well as prognostic validation, are not part of the study. | — |
Countries
Germany
Contacts
Public ContactChristoph Wallner
Universitätsklinik für Plastische Chirurgie, Handchirurgie und Schwerbrandverletzte, BG Universitätsklinikum Bergmannsheil gGmbH
Outcome results
None listed